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Dose-response: Exercise Therapy on Hip Osteoarthritis

Primary Purpose

Osteoarthritis, Hip

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
High-Dosage Exercise Therapy
Low-Dosage Exercise Therapy
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Exercise therapy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least three month since debut of the disease
  • Age above 45 years
  • Ability to complete the intervention

Exclusion Criteria:

  • Pain above 4 on VAS during gait
  • Pregnancy
  • Autoimmune disease
  • Cardiovascular disease
  • Respiratory disease
  • Metabolic disease
  • Neurological signs
  • Planned hip-replacement surgery within the next year
  • Received exercise therapy within the last 3 months

Sites / Locations

  • Fysioterapitjenesten i Ørsta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

High-dosage-group

Low-dosage-group

Arm Description

Outcomes

Primary Outcome Measures

WOMAC Index of Osteoarthritis (questionnaire)
WOMAC Index of Osteoarthritis (questionnaire)

Secondary Outcome Measures

HAD questionnaire
Tampa Scale for Kinesiophobia
Squats
Number of squats completed in 30 seconds.
Stairs
Time used to walk up and down 12 steps.

Full Information

First Posted
October 1, 2012
Last Updated
September 19, 2017
Sponsor
Norwegian University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01700933
Brief Title
Dose-response: Exercise Therapy on Hip Osteoarthritis
Official Title
Dose-response: Exercise Therapy on Hip Osteoarthritis, a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Osteoarthritis is a common disease that causes muscle weakness, stiffness and instability. The disease reduces the opportunities for an active lifestyle. Exercise Therapy provides a well-documented effect on pain and function in patients with osteoarthritis of the hip. It is sought an optimal dose of exercise, in which this study will help to investigate. We hypothesize that an exercise program designed to have a high number of repetitions will benefit the outcome of the training in a more positive way than a low-repetition based program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
Keywords
Exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-dosage-group
Arm Type
Active Comparator
Arm Title
Low-dosage-group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
High-Dosage Exercise Therapy
Intervention Description
Structure of the exercise program done three times per week, for eight weeks: 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)
Intervention Type
Other
Intervention Name(s)
Low-Dosage Exercise Therapy
Intervention Description
Structure of the exercise program done three times per week, for eight weeks: 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)
Primary Outcome Measure Information:
Title
WOMAC Index of Osteoarthritis (questionnaire)
Description
WOMAC Index of Osteoarthritis (questionnaire)
Time Frame
0 weeks, 8 weeks, 6 months postinterventional
Secondary Outcome Measure Information:
Title
HAD questionnaire
Time Frame
0 weeks, 8 weeks, 6 months postinterventional
Title
Tampa Scale for Kinesiophobia
Time Frame
0 weeks, 8 weeks, 6 months postinterventional
Title
Squats
Description
Number of squats completed in 30 seconds.
Time Frame
0 weeks, 8 weeks, 6 months postinterventional
Title
Stairs
Description
Time used to walk up and down 12 steps.
Time Frame
0 weeks, 8 weeks, 6 months postinterventional

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least three month since debut of the disease Age above 45 years Ability to complete the intervention Exclusion Criteria: Pain above 4 on VAS during gait Pregnancy Autoimmune disease Cardiovascular disease Respiratory disease Metabolic disease Neurological signs Planned hip-replacement surgery within the next year Received exercise therapy within the last 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håvard Østerås
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fysioterapitjenesten i Ørsta
City
Ørsta
ZIP/Postal Code
6154
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28532870
Citation
Osteras H, Paulsberg F, Olsen SE, Osteras B, Torstensen TA. Effects of medical exercise therapy in patients with hip osteoarthritis: A randomized controlled trial with six months follow-up. A pilot study. J Bodyw Mov Ther. 2017 Apr;21(2):284-289. doi: 10.1016/j.jbmt.2016.06.016. Epub 2016 Jul 5.
Results Reference
result

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Dose-response: Exercise Therapy on Hip Osteoarthritis

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